Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 41050-41053 [2020-14715]
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Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Notices
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ORR–5 is designed to
satisfy the statutory requirements of the
Immigration and Nationality Act (INA).
Section 412(a)(3) of INA (8 U.S.C.
1522(a)(3)) requires that the Director of
ORR make a periodic assessment of the
needs of refugees for assistance and
services and the resources available to
meet those needs. ORR proposes an
extension with no changes to the
current form until January 31, 2021, to
ensure continuous information
collection for FY 2020. ORR also
proposes revisions to the current form
for use after FY 2020. Revisions include
collecting additional client-level data
elements on the ORR–5 at multiple
points in time, which will allow the
ORR Director to better understand client
goals, services utilized, and the
outcomes achieved by the population
ORR serves. New data elements include
additional demographics, primary goals
identified and referrals made to work
toward self-sufficiency, progress made
toward achieving said goals, and
employment status of employable
refugees 12 months post-enrollment.
The data collected will inform evidencebased policy making and program
design. These revisions also enable ORR
to monitor implementation of the
requirements put forth in Policy Letter
19–07.
Respondents: States, Replacement
Designees, and the District of Columbia.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
Refugee Data Submission for Formula Funds Allocations
(ORR–5)—Current (through January 31, 2021) ..............
Refugee Data Submission for Formula Funds Allocations
(ORR–5)—Revised ...........................................................
Total
number of
responses per
respondent
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
50
1
22
1,100
* 367
50
3
42
6,300
2,100
* Burden is annualized over the full 3-year request period, but this form will be complete within the 1st year.
Estimated Total Annual Burden
Hours: 2,467.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 8 U.S.C. 1522(a)(3).
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–14674 Filed 7–7–20; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Administration for Community Living
Reallotment of FY 2020 Funds
Administration on Disabilities
(AoD), Administration for Community
Living (ACL), U.S. Department of Health
and Human Services (HHS).
AGENCY:
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ACTION:
Notice of reallotment of FY 2020
funds.
AOD intends to reallot funds
under the authority of Section 122(e)
and Section 142(a)(1) of the
Development Disabilities Assistance
and Bill of Rights Act of 2000 (Pub. L.
106–402). AOD will be reallotting FY
2020 funds awarded to the State Council
on Developmental Disabilities (SCDD)
located within the Commonwealth of
Puerto Rico. This determination is based
on the limited reported expenditures
and requests for reimbursement over the
last several years from the SCDD in the
Commonwealth of Puerto Rico. The
Puerto Rico SCDD will have up to $1.8
million rescinded and proportionately
redistributed to the remaining SCDDs.
SCDDs that receive FY 2020 realloted
funds will have through the end of FY
2020 to obligate the funds and until the
end of FY 2022 to liquidate the funds.
Realloted funds for the SCDDs must be
used according to the terms as outlined
in the FY 2020 Notice of Award for each
program.
DATES: Funds will be realloted after
August 14, 2020 and before September
30, 2020.
FOR FURTHER INFORMATION CONTACT:
Allison Cruz, Office of Intellectual and
Developmental Disabilities,
Administration on Disabilities,
Administration for Community Living,
330 C St. SW, Washington, DC 20201.
Telephone (202) 795–7408. Email
allison.cruz@acl.hhs.gov. Please note
the telephone number is not toll free.
SUMMARY:
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This document will be made available
in alternative formats upon request.
Written correspondence can be sent to
Administration for Community Living,
U.S. Department of Health and Human
Services, 330 C St. SW, Washington, DC
20201.
SUPPLEMENTARY INFORMATION: The
Development Disabilities Assistance
and Bill of Rights Act of 2000 (Pub. L.
106–402) states: ‘‘If the Secretary
determines that an amount of an
allotment to a State for a period (of a
fiscal year or longer) will not be
required by the State during the period
for the purpose for which the allotment
was made, the Secretary may reallot the
amount.’’
Dated: June 26, 2020.
Julie E. Hocker,
Commissioner, Administration on
Disabilities.
[FR Doc. 2020–14616 Filed 7–7–20; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2256]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
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Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Notices
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may be self-nominated or
may be nominated by a consumer
organization.
SUMMARY:
Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
DATES:
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by August 7, 2020, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by August 7, 2020.
Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2020.
All statements of interest
from consumer organizations interested
in participating in the selection process
should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5122, Silver Spring,
MD 20993–0002.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
ADDRESSES:
41051
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm or by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5122, Silver Spring, MD 20993–
0002. Additional information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
For
questions relating to participation in the
selection process: Kimberly Hamilton,
Advisory Committee Oversight and
Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5122, Silver Spring,
MD 20993–0002, 301–796–8220,
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate Contact Person listed in
table 1.
FOR FURTHER INFORMATION CONTACT:
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person
Committee/panel
Kathleen Hayes, Center for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993–0002, 301–
796–7864, Kathleen.Hayses@fda.hhs.gov.
LaTonya Bonner, Center for Drugs Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20992–0002, 301–796–
2855, Latoya.Bonner@fda.hhs.gov.
Philip Bautista, Center for Drugs Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20992–0002, 240–762–
8729, Philip.Bautista@fda.hhs.gov.
Kalyani Bhatt, Center for Drugs Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–0002, 301–796–
9005, Kalyani.Bhatt@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993–0002, 301–796–
6875, Patricio.Garcia@fda.hhs.gov.
James Swink, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5211 Silver Spring, MD 20993–0002, 301–796–
7047, James.Swink@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–0002, 301–796–0400,
Aden.Asefa@fda.hhs.gov.
FDA seeks
to include the views of women and
men, members of all racial and ethnic
groups, and individuals with and
SUPPLEMENTARY INFORMATION:
without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Allergenic Products Advisory Committee.
Dermatologic and Ophthalmic Drugs Advisory
Committee.
Drug Safety and Risk Advisory Committee.
Psychopharmacologic Drugs Advisory Committee.
Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology
Devices Panel, Obstetrics and Gynecology
Devices Panel.
Circulatory Systems Devices Panel, Dental
Products Devices Panel, National Mammography Advisory Committee, Radiological Devices Panel.
Immunology Devices Panel; Microbiology Devices Panel.
FDA is requesting nominations for
voting and/or nonvoting consumer
representatives for the vacancies listed
in table 2:
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Committee/panel/areas of expertise needed
Type of
vacancy
Allergenics Advisory Committee—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties.
Dermatologic and Ophthalmic Advisory Committee—Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions.
1—Voting .......
August 2020.
1—Voting .......
Immediately.
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Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Notices
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Committee/panel/areas of expertise needed
Type of
vacancy
Drug Safety and Risk Management Advisory Committee—Knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug
abuse.
Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.
Clinical Chemistry and Clinical Toxicology Devices Panel—Doctor of Medicine or philosophy with experience
in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology.
Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists and nephrologists.
Obstetrics and Gynecology Devices Panel—Experts in perinatology, embryology, reproductive endocrinology,
pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electro-surgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and
colposcopy; biostatisticians and engineers with experience in obstetrics/gynecology devices;
urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic
(optical) spectroscopy; experts in midwifery; labor and delivery nursing.
Dental Products Device Panel—Dentists, engineers and scientists who have expertise in the areas of dental
implants, dental materials, periodontology, tissue engineering, and dental anatomy.
National Mammography Advisory Committee—Physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.
Circulatory Systems Devices Panel—Interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart
failure.
Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
Microbiology Devices Panel—Clinicians with an expertise in infectious disease, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical
medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists
Radiology Devices Panel—Physicians with experience in general radiology, mammography, ultrasound, magnetic resonance, computed tomography, other radiological subspecialties and radiation oncology; scientists
with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging and image analysis.
1—Voting .......
Immediately.
1—Voting .......
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
1—Non-Voting
Immediately.
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
I. Functions and General Description of
the Committee Duties
of dermatologic and ophthalmic
disorders.
E. Certain Panels of the Medical Devices
Advisory Committee
A. Allergenics Advisory Committee
C. Drug Safety and Risk Management
Advisory Committee
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational devices and makes
recommendations for their regulation.
With the exception of the Medical
Devices Dispute Resolution Panel, each
panel, according to its specialty area,
advises on the classification or
reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the Federal Food, Drug, and
Cosmetic Act; advises on the necessity
to ban a device; and responds to
requests from the Agency to review and
make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
Reviews and evaluates available data
concerning the safety, effectiveness, and
adequacy of labeling of marketed and
investigational allergenic biological
products or materials that are
administered to humans for the
diagnosis, prevention, or treatment of
allergies and allergic disease as well as
the affirmation or revocation of
biological product licenses, on the
safety, effectiveness, and labeling of the
products, on clinical and laboratory
studies of such products, on
amendments or revisions to regulations
governing the manufacture, testing and
licensing of allergenic biological
products, and on the quality and
relevance of FDA’s research programs.
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Approximate
date needed
B. Dermatologic and Ophthalmic Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
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Risk management, risk
communication, and quantitative
evaluation of spontaneous reports for
drugs for human use and for any other
product for which FDA has regulatory
responsibility. Scientific and medical
evaluation of all information gathered
by the Department of Health and Human
Services (HHS) and the Department of
Justice with regard to safety, efficacy,
and abuse potential of drugs or other
substances, and recommends actions to
be taken by HHS with regard to the
marketing, investigation, and control of
such drugs or other substances.
D. Psychopharmacologic Drugs
Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
products for use in the practice of
psychiatry and related fields.
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Federal Register / Vol. 85, No. 131 / Wednesday, July 8, 2020 / Notices
according to its specialty area, may also
make appropriate recommendations to
the Commissioner of Food and Drugs on
issues relating to the design of clinical
studies regarding the safety and
effectiveness of marketed and
investigational devices.
The Dental Products Panel also
functions at times as a dental drug
panel. The functions of the dental drug
panel are to evaluate and recommend
whether various prescription drug
products should be changed to over-thecounter status and to evaluate data and
make recommendations concerning the
approval of new dental drug products
for human use.
The Medical Devices Dispute
Resolution Panel provides advice to the
Commissioner on complex or contested
scientific issues between FDA and
medical device sponsors, applicants, or
manufacturers relating to specific
products, marketing applications,
regulatory decisions and actions by
FDA, and Agency guidance and
policies. The Panel makes
recommendations on issues that are
lacking resolution, are highly complex
in nature, or result from challenges to
regular advisory panel proceedings or
Agency decisions or actions.
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II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) Demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
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in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or re´sume´.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
current, complete re´sume´ or curriculum
vitae for each nominee and a signed
copy of the ‘‘Acknowledgement and
Consent’’ form available at the FDA
Advisory Committee Nomination Portal
(see ADDRESSES), and a list of consumer
or community-based organizations for
which the candidate can demonstrate
active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
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41053
voting or nonvoting consumer
representatives will not participate in
the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14715 Filed 7–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1330]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cardiovascular and Renal
Drugs Advisory Committee. This notice
is being published less than 15 days
prior to the date of the meeting. The
general function of the committee is to
provide advice and recommendations to
FDA on regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document
DATES: The meeting will be held on July
15, 2020, from 8 a.m. to 5 p.m.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2020–N–1330.
The docket will close on July 14, 2020.
Submit either electronic or written
comments on this public meeting by
July 14, 2020. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 14, 2020.
The https://www.regulations.gov
electronic filing system will accept
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
[Notices]
[Pages 41050-41053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14715]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2256]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
[[Page 41051]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by August
7, 2020, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by August 7, 2020. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2020.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected] or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002, 301-796-8220, [email protected].
For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Kathleen Hayes, Center for Biologics Allergenic Products
Evaluation and Research, Food and Drug Advisory Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
0002, 301-796-7864,
[email protected].
LaTonya Bonner, Center for Drugs Evaluation Dermatologic and
and Research, Food and Drug Administration, Ophthalmic Drugs
10903 New Hampshire Ave., Bldg. 31, Rm. Advisory Committee.
2428, Silver Spring, MD 20992-0002, 301-796-
2855, [email protected].
Philip Bautista, Center for Drugs Evaluation Drug Safety and Risk
and Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2430, Silver Spring, MD 20992-0002, 240-762-
8729, [email protected].
Kalyani Bhatt, Center for Drugs Evaluation Psychopharmacologic Drugs
and Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2438, Silver Spring, MD 20993-0002, 301-796-
9005, [email protected].
Patricio Garcia, Center for Devices and Clinical Chemistry and
Radiological Health, Food and Drug Clinical Toxicology
Administration, 10903 New Hampshire Ave., Devices Panel,
Bldg. 66, Rm. 5216, Silver Spring, MD 20993- Gastroenterology and
0002, 301-796-6875, Urology Devices Panel,
[email protected]. Obstetrics and
Gynecology Devices
Panel.
James Swink, Center for Devices and Circulatory Systems
Radiological Health, Food and Drug Devices Panel, Dental
Administration, 10903 New Hampshire Ave., Products Devices Panel,
Bldg. 66, Rm. 5211 Silver Spring, MD 20993- National Mammography
0002, 301-796-7047, [email protected]. Advisory Committee,
Radiological Devices
Panel.
Aden Asefa, Center for Devices and Immunology Devices Panel;
Radiological Health, Food and Drug Microbiology Devices
Administration, 10903 New Hampshire Ave., Panel.
Bldg. 66, Rm. 5214, Silver Spring, MD 20993-
0002, 301-796-0400, [email protected].
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA seeks to include the views of women and
men, members of all racial and ethnic groups, and individuals with and
without disabilities on its advisory committees and, therefore,
encourages nominations of appropriately qualified candidates from these
groups.
FDA is requesting nominations for voting and/or nonvoting consumer
representatives for the vacancies listed in table 2:
Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenics Advisory Committee--Knowledgeable 1--Voting...................... August 2020.
in the fields of allergy, immunology,
pediatrics, internal medicine, biochemistry,
and related specialties.
Dermatologic and Ophthalmic Advisory 1--Voting...................... Immediately.
Committee--Knowledgeable in the fields of
dermatology, ophthalmology, internal
medicine, pathology, immunology, epidemiology
or statistics, and other related professions.
[[Page 41052]]
Drug Safety and Risk Management Advisory 1--Voting...................... Immediately.
Committee--Knowledgeable in risk
communication, risk management, drug safety,
medical, behavioral, and biological sciences
as they apply to risk management, and drug
abuse.
Psychopharmacologic Drugs Advisory Committee-- 1--Voting...................... Immediately.
Knowledgeable in the fields of
psychopharmacology, psychiatry, epidemiology
or statistics, and related specialties.
Clinical Chemistry and Clinical Toxicology 1--Non-Voting.................. Immediately.
Devices Panel--Doctor of Medicine or
philosophy with experience in clinical
chemistry (e.g., cardiac markers), clinical
toxicology, clinical pathology, clinical
laboratory medicine, and endocrinology.
Gastroenterology and Urology Devices Panel-- 1--Non-Voting.................. Immediately.
Gastroenterologists, urologists and
nephrologists.
Obstetrics and Gynecology Devices Panel-- 1--Non-Voting.................. Immediately.
Experts in perinatology, embryology,
reproductive endocrinology, pediatric
gynecology, gynecological oncology, operative
hysteroscopy, pelviscopy, electro-surgery,
laser surgery, assisted reproductive
technologies, contraception, postoperative
adhesions, and cervical cancer and
colposcopy; biostatisticians and engineers
with experience in obstetrics/gynecology
devices; urogynecologists; experts in breast
care; experts in gynecology in the older
patient; experts in diagnostic (optical)
spectroscopy; experts in midwifery; labor and
delivery nursing.
Dental Products Device Panel--Dentists, 1--Non-Voting.................. Immediately.
engineers and scientists who have expertise
in the areas of dental implants, dental
materials, periodontology, tissue
engineering, and dental anatomy.
National Mammography Advisory Committee-- 1--Non-Voting.................. Immediately.
Physician, practitioner, or other health
professional whose clinical practice,
research specialization, or professional
expertise includes a significant focus on
mammography.
Circulatory Systems Devices Panel-- 1--Non-Voting.................. Immediately.
Interventional cardiologists,
electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic
surgeons, and cardiologists with special
interest in congestive heart failure.
Immunology Devices Panel--Persons with 1--Non-Voting.................. Immediately.
experience in medical, surgical, or clinical
oncology, internal medicine, clinical
immunology, allergy, molecular diagnostics,
or clinical laboratory medicine.
Microbiology Devices Panel--Clinicians with an 1--Non-Voting.................. Immediately.
expertise in infectious disease, e.g.,
pulmonary disease specialists, sexually
transmitted disease specialists, pediatric
infectious disease specialists, experts in
tropical medicine and emerging infectious
diseases, mycologists; clinical
microbiologists and virologists; clinical
virology and microbiology laboratory
directors, with expertise in clinical
diagnosis and in vitro diagnostic assays,
e.g., hepatologists; molecular biologists
Radiology Devices Panel--Physicians with 1--Non-Voting.................. Immediately.
experience in general radiology, mammography,
ultrasound, magnetic resonance, computed
tomography, other radiological subspecialties
and radiation oncology; scientists with
experience in diagnostic devices, radiation
physics, statistical analysis, digital
imaging and image analysis.
----------------------------------------------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. Allergenics Advisory Committee
Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease as well as the affirmation or revocation of biological
product licenses, on the safety, effectiveness, and labeling of the
products, on clinical and laboratory studies of such products, on
amendments or revisions to regulations governing the manufacture,
testing and licensing of allergenic biological products, and on the
quality and relevance of FDA's research programs.
B. Dermatologic and Ophthalmic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of dermatologic and ophthalmic disorders.
C. Drug Safety and Risk Management Advisory Committee
Risk management, risk communication, and quantitative evaluation of
spontaneous reports for drugs for human use and for any other product
for which FDA has regulatory responsibility. Scientific and medical
evaluation of all information gathered by the Department of Health and
Human Services (HHS) and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by HHS with regard to the marketing,
investigation, and control of such drugs or other substances.
D. Psychopharmacologic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human products for use in the practice
of psychiatry and related fields.
E. Certain Panels of the Medical Devices Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel,
[[Page 41053]]
according to its specialty area, may also make appropriate
recommendations to the Commissioner of Food and Drugs on issues
relating to the design of clinical studies regarding the safety and
effectiveness of marketed and investigational devices.
The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
``Acknowledgement and Consent'' form available at the FDA Advisory
Committee Nomination Portal (see ADDRESSES), and a list of consumer or
community-based organizations for which the candidate can demonstrate
active participation.
Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: July 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14715 Filed 7-7-20; 8:45 am]
BILLING CODE 4164-01-P
